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Telmisartan With or Without Hydrochlorothiazide (HCTZ) Compared With Losartan With or Without HCTZ in Mild to Moderate Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT02172586
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12 weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement).

Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of treatment and at the end of the study, evaluated by sphygmomanometric blood pressure measurement and ABPM

Safety:

Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters


Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan Drug: Losartan Drug: Hydrochlorothiazide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PROBE (Prospective, Randomised, Open-label, Blinded Endpoint) Trial to Investigate the Efficacy and Safety of Telmisartan 40-80 mg Once Daily Compared With Losartan 50-100 mg Once Daily Over a Period of 12 Weeks, and of Telmisartan 80 mg + HCTZ 12.5 mg Once Daily Compared With Losartan 100 mg Once Daily + HCTZ 12.5 mg Once Daily Over a Period of Further 12 Weeks in Mild to Moderate Hypertensive Patients (Grade 1 and Grade 2 WHO-ISH Guidelines 1999)
Study Start Date : January 2000
Actual Primary Completion Date : January 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telmisartan Drug: Telmisartan
Experimental: Telmisartan + Hydrochlorothiazide Drug: Telmisartan
Drug: Hydrochlorothiazide
Active Comparator: Losartan Drug: Losartan
Active Comparator: Losartan + Hydrochlorothiazide Drug: Losartan
Drug: Hydrochlorothiazide



Primary Outcome Measures :
  1. Change from baseline in diastolic blood pressure (DBP) during the last 6 hours (ABPM - ambulatory blood pressure measurement) of the 24-hour dosing interval at the end of the monotherapy period of treatment [ Time Frame: Baseline and week 12 ]

Secondary Outcome Measures :
  1. Change from baseline in DBP during the last 6 hours (ABPM) of the 24-hour dosing interval at the end of the study [ Time Frame: Baseline and week 24 ]
  2. Change from baseline in systolic blood pressure (SBP) during the last 6 hours (ABPM) of the 24-hour dosing interval [ Time Frame: Baseline, week 12 and 24 ]
  3. Change from baseline in DBP/SBP during the last 2 hours (ABPM) of the 24-hour dosing interval (trough BP) [ Time Frame: Baseline, week 12 and 24 ]
  4. Changes from baseline in trough cuff (sphygmomanometer) SBP/DBP [ Time Frame: Baseline, week 12 and 24 ]
  5. Changes from baseline in SBP/DBP of 24 hours mean ABPM [ Time Frame: Baseline, week 12 and 24 ]
  6. Comparison of SBP/DBP ABPM tracing profile [ Time Frame: Week 12 and 24 ]
  7. Smoothness index in comparison with baseline [ Time Frame: Baseline, week 12 and 24 ]
  8. Number of responders [ Time Frame: Week 12 and 24 ]
  9. Number of controlled responders [ Time Frame: Week 12 and 24 ]
  10. Number of patients who withdraw due to lack of efficacy [ Time Frame: 24 weeks ]
  11. Number of patients with adverse events [ Time Frame: 24 weeks ]
  12. Number of patients who withdraw due to adverse events [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Mild-to-moderate essential hypertension defined as a mean diastolic blood pressure (DBP) ≥ 95 mmHg and < 110 mmHg and systolic blood pressure (SBP) < 180 mmHg measured by manual cuff sphygmomanometer at the end of the wash-out period
  • Written informed consent

Exclusion Criteria:

  • Nursing, pregnancy or childbearing potential women, post-menopausal women will be enrolled with last menstruation > 1 year prior to start wash-out phase or surgically sterile
  • Secondary hypertension
  • Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)
  • Clinically significant sodium depletion as defined by serum sodium level < 130 mEq/L and/or clinically significant hyperkaliemia as defined by serum potassium level > 5.5 mEq/L or clinically significant hypokaliemia as defined by serum potassium level < 3.0 mEq/L
  • Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which, in the investigator opinion could compromise patient's participation to the trial
  • Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV)
  • Angina pectoris or myocardial infarction
  • Cardiac surgery within the past 3 months prior to start the wash-out period
  • Stroke within the past 6 months prior to start the wash-out period
  • Renal insufficiency defined as creatininaemia > 2mg/dl
  • Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post renal transplant, presence of only one functioning kidney
  • Liver insufficiency, defined as bilirubinaemia > 2mg/dl and AST (aspartate aminotransferase) or ALT (alanine-aminotransferase) > twice the upper normal range
  • Clinically significant metabolic and endocrine disease
  • Autoimmune disease
  • Previous history of angioedema
  • Body mass index > 30kg/m2
  • Arm circumference > 32 cm
  • Any condition that may be likely to compromise patients participation to the trial (alcohol or drug abuse, disability illness, etc.)
  • Concomitant therapy with antihypertensive drugs non permitted by protocol, corticosteroids or drugs known to affect blood pressure
  • Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ)
  • Investigational drug treatment within the past 30 days before the enrolment or concurrent participation to any other trial
  • Sensitivity, significant adverse reaction or contraindications to the study drugs (telmisartan, losartan, HCTZ)
  • Predictable lack of patient co-operation

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02172586     History of Changes
Other Study ID Numbers: 502.316
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Hydrochlorothiazide
Telmisartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators